UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024606
Receipt number R000028313
Scientific Title Effect of vitamin E to basal energy expenditure in NAFLD patients
Date of disclosure of the study information 2017/11/18
Last modified on 2020/06/03 17:14:52

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Basic information

Public title

Effect of vitamin E to basal energy expenditure in NAFLD patients

Acronym

Effect of vitamin E to basal energy expenditure in NAFLD patients

Scientific Title

Effect of vitamin E to basal energy expenditure in NAFLD patients

Scientific Title:Acronym

Effect of vitamin E to basal energy expenditure in NAFLD patients

Region

Japan


Condition

Condition

Non-alcoholic fatty liver disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of vitamin E to basal energy expenditure in patients with NAFLD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Beneficial effect of vitamin E to basal energy expenditure for 1 year

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

600 mg of vitamin E for 1year

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who were diagnosed as NAFLD

Key exclusion criteria

Patients with decompensated-liver cirrhosis
Patients with cancer

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Takikawa

Organization

Iwate medical university

Division name

Division of Hepatology, Department of Internal medicine

Zip code

0208505

Address

19-1 Uchimaru, Morioka, Iwate

TEL

0196515111

Email

ytakikaw@iwate-med.ac.jp


Public contact

Name of contact person

1st name Keisuke
Middle name
Last name Kakisaka

Organization

Iwate medical university

Division name

Division of Hepatology, Department of Internal medicine

Zip code

0208505

Address

19-1 Uchimaru, Morioka, Iwate

TEL

0196515111

Homepage URL


Email

keikaki@iwate-med.ac.jp


Sponsor or person

Institute

Iwate medical university

Institute

Department

Personal name



Funding Source

Organization

Iwate medical university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Iwate Medical University

Address

Uchimaru 19-1

Tel

019-651-5111

Email

yoshiday@iwate-med.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

H28-71

Org. issuing International ID_1

Iwate medical university

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 18 Day


Related information

URL releasing protocol

NA

Publication of results

Unpublished


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

17

Results

Vitamin E increased energy expenditure although there was no control group. According to this results, further study will be required.

Results date posted

2020 Year 06 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

NAFLD

Participant flow

17

Adverse events

no

Outcome measures

Increase of energy expenditure

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 09 Month 21 Day

Date of IRB

2016 Year 09 Month 02 Day

Anticipated trial start date

2016 Year 09 Month 22 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2018 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 28 Day

Last modified on

2020 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028313


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name